Human Factors Risk Assessment

In the medical device industry, analysing the risk of use error is an essential activity in the usability engineering process, which contributes to your risk analysis activities.

Use error (or design-induced human error) is thought to be a contributing factor in as many as 1 in 5 medical device incidents (as described below), making it a heightened topic for regulatory authorities.

As required in IEC 62366, manufacturers need to verify and validate the effectiveness of risk control measures to prevent, or reduce the risk of, use-related hazards or hazardous situations.

Our human factors risk assessment service consists of the following analytical techniques:

Criticality Analysis: In order to make best use of time and resources, we can help prioritise tasks for subsequent analyses based on human factors principles and task criticality.

Task Analysis: We use software tools to systematically break down the device use process into discrete steps or sequences in order to analyse the efficiency, effectiveness and simplicity of user interactions.

Use Error Analysis/Human FMEA: We can analyse possible use errors and assess the adequacy of risk control measures. Further, we can conduct a review of the FDA’s MAUDE and MedSun databases for evidence of use-related issues with devices similar to yours.

We are also able to develop user-interface requirements, usability goals/acceptance criteria, and use case scenarios based on the results of these analyses.

When a device is involved in a incident or near miss, we are able to investigate the root causes which may include human, technical, social and environmental factors.

Our investigation process often begins with a task analysis workshop (if not previously carried out) to identify at what point the use error/incident occurred. Incident investigation techniques, such as RCA, are then carried out to explore causes and actions required to prevent recurrence.

Where there are legal disputes following an incident or disputed injury, BERGO also offers an expert witness service to organisations seeking an unbiased, independent written opinion on the contributing factors.

The main reason for usability being revised and escalated in the latest revision of the essential requirements in Directive 2007/47/EC, was due to the concerns that regulatory authorities had and still have about the lack of structure of, and attention to, use-related risks.

As many as 1 in 5 medical device incidents are thought to relate to use error. The FDA also stipulate that human factors plays a role in virtually all medical device incidents.